Casodex 150mg Tablet

In patients with locally advanced prostate cancer (T3-4, any N, M0/T1-2, N+, M0) CASODEX 150 is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. CASODEX 150 is indicated as monotherapy for the management of patients with locally advanced, non-metastatic prostate cancer for whom surgical or medical castration is not appropriate.

Adult males including the elderly: 150 mg once a day for 2 years or until progression. Renal impairment: no dosage adjustment is necessary for patients with renal impairment. Hepatic impairment: no dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see under u201c Special precautions u201d).

CASODEX 150 is contraindicated in females and children. CASODEX 150 must not be given to any patient who has shown a hypersensitivity reaction to the bicalutamide or to any of the excipients of CASODEX 150.

CASODEX 150 is extensively metabolised in the liver. Data suggests that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of CASODEX 150. Therefore, CASODEX 150 should be used with caution in patients with moderate to severe hepatic impairment. Periodic liver function testing should be considered due to the possibility of hepatic changes. Severe hepatic changes and hepatic failure have been observed rarely with CASODEX 150, and fatal outcomes have been reported (see u201c Side Effects u201d). CASODEX 150 therapy should be discontinued if changes are severe. Clinically discontinuation of Casodex can result in anti-androgen withdrawal syndrome in a subset of patients. This is characterised by a decline in PSA (prostate specific antigen) or clinical response following withdrawal of the anti-androgen component of Maximal Androgen Blockade (MAB). This syndrome has been well described in scientific literature although the pathophysiology is unknown and may reflect multiple mechanisms, but is believed to represent the development of agonistic activity by the medicine at the receptor level due to receptor mutations with advancing disease. Although this effect has only been reported with the 50 mg dose (approved for use in combination therapy), given the likely mode of action the phenomenon could theoretically occur with the 150 mg dose used as single agent therapy. Lactose warning: The tablets contain lactose anhydrous. Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take CASODEX 150.

In vitro studies have shown that (R)-CASODEX is an inhibitor of CYP 3A4, with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Although clinical studies using antipyrine as a marker of cytochrome P450 (CYP) activity showed no evidence of a CASODEX 150 interaction potential with CASODEX 150, the mean midazolam exposure (AUC) was increased by up to 80 %, after co-administration of CASODEX 150 for 28 days. This rise is comparable to that seen in other studies after administration of grapefruit juice. An increase of this magnitude is may to be of clinical significance for medicines with a narrow therapeutic index (e.g. astemizole, cisapride and ciclosporin) such an increase could be of relevance. As such, caution should be exercised with the co-administration of CASODEX 150 with compounds such as these. In vitro studies have shown that CASODEX 150 can displace the coumarin anticoagulant, warfarin, from its protein binding sites. It is therefore recommended that if CASODEX 150 is started in patients who are already receiving coumarin anticoagulants, prothrombin time should be closely monitored.

CASODEX 150 is contraindicated in females and must not be given to pregnant women or nursing mothers.

During treatment with CASODEX, somnolence has been reported and those patients who experience this symptom should not drive or use machines.

Unless specified, the following frequency categories were assigned based on the incidence of the adverse event in the CASODEX 150 arm of the combined Early Prostate Cancer studies (for CASODEX monotherapy). Frequency System Organ Class Adverse Event Very common ( uf0b3 10 %) Skin and subcutaneous tissue disorders Rash Reproductive system and breast disorders Gynaecomastia 1 Breast tenderness 1 Frequency System Organ Class Adverse Event Very common ( uf0b3 10 %) General disorders and administration site conditions Asthenia Common ( uf0b3 1 % and < 10 %) Blood and lymphatic Anaemia General disorders and administration site conditions Chest pain Oedema Psychiatric disorders Decreased libido Depression Skin and subcutaneous tissue disorders Alopecia Hirsutism/ Hair re-growth Dry skin 3 Pruritus Nervous system disorders Dizziness Somnolence Vascular disorders Hot flush Reproductive system and breast disorders Erectile dysfunction Metabolism and nutrition disorders Decreased appetite Frequency System Organ Class Adverse Event Common ( uf0b3 1 % and 0,1 % and 0,01 % and < 0,1 %) Hepatobiliary disorders Fatal outcomes have been reported 1 The majority of patients receiving CASODEX 150 as monotherapy experience gynaecomastia and/or breast pain. In studies these symptoms were considered to be severe in up to 5% of the patients. Gynaecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment. 2 Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy. 3 Due to the coding conventions used in the EPC studies, adverse events of u2018dry skinu2019 were coded under the COSTART term of u2018rashu2019. No separate frequency descriptor can therefore be determined from the CASODEX 150 dose however the same frequency as the CASODEX 50 dose is assumed.

There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic. Dialysis may not be helpful, since CASODEX 150 is highly protein bound and is not recovered unchanged in the urine. General supportive care, including frequent monitoring of vital signs, is indicated.